drugset / Trial / NCT04319900

Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

NCT04319900

Phase 2/3 Unknown 150 enrolled Beijing Chao Yang Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is a multi-centered, three-armed, randomized, double-blinded, controlled study, namely, the oral trial drug favipiravir tablets plus chloroquine phosphatetablets tablets group (combined group), the oral trial drug favipiravir tablets group (pirovir group), and the oral placebo treatment group (control group). The total number of enrolled cases in this study was set at 150. During the treatment, the clinical data of the subjects were collected, the changes of viral load and biochemical indicators were detected, and the outcome of the subjects was monitored. The main indicators of efficacy include improvement or recovery of respiratory symptoms and viral nucleic acid shedding. The rate of progression to severe disease, duration of fever, peripheral blood index and improvement time of pulmonary imaging were the secondary indicators to evaluate the efficacy. Statistical analysis was performed at the middle and final stages of the study to evaluate the efficacy and safety of favipiravir tablets combined with chloroquine phosphatetablets tablets in the treatment of novel coronavirus pneumonia.

Timeline

Start
2020-03-05
Primary completion
2020-04-30
Completion
2020-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Chloroquine Small molecule 250 mg Oral
Subject Favipiravir Small molecule 600 mg Oral

Indications